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ASTM F3358-18

(Practice)

Standard Practice for Labeling and Information for Exoskeletons

Standard Practice for Labeling and Information for Exoskeletons

SIGNIFICANCE AND USE
4.1 This practice contains the recommendations for minimal informational requirements for the identification of exoskeletons. It is intended to provide the user with some of the basic information necessary for the selection and use of the exoskeletons.  
4.2 Additional information beyond the content recommended by this practice is permitted to be applied to the label.
SCOPE
1.1 This practice sets forth labeling and instruction guidelines for manufacturers of exoskeletons.  
1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

Status
Historical
Publication Date
30-Nov-2018
ICS
11.180.10 - Aids and adaptation for moving
25.040.30 - Industrial robots. Manipulators
Technical Committee
F48 - Exoskeletons and Exosuits
Drafting Committee
F48.01 - Design and Manufacturing
Current Stage
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ASTM F3358-18 - Standard Practice for Labeling and Information for Exoskeletons
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3358 − 18
Standard Practice for
1
Labeling and Information for Exoskeletons
This standard is issued under the fixed designation F3358; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Terminology
1.1 This practice sets forth labeling and instruction guide- 3.1 Definitions:
lines for manufacturers of exoskeletons. 3.1.1 accompanying literature, n—printed material or elec-
tronic records that accompanies the product when it is sold or
1.2 The values stated in SI units are to be regarded as
distributed.
standard. The values given in parentheses are mathematical
3.1.2 contact information, n—information that allows a user
conversions to inch-pound units that are provided for informa-
to contact the manufacturer of the product, such as name,
tion only and are not considered standard.
telephone number, and website address.
1.3 This standard does not purport to address all of the
3.1.3 date of manufacture, n—uncoded month and four-digit
safety concerns, if any, associated with its use. It is the
year during which the exoskeleton was manufactured.
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
4. Significance and Use
mine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accor-
4.1 This practice contains the recommendations for minimal
dance with internationally recognized principles on standard-
informational requirements for the identification of exoskel-
ization established in the Decision on Principles for the
etons. It is intended to provide the user with some of the basic
Development of International Standards, Guides and Recom-
information necessary for the selection and use of the exoskel-
mendations issued by the World Trade Organization Technical
etons.
Barriers to Trade (TBT) Committee.
4.2 Additional information beyond the content recom-
mended by this practice is permitted to be applied to the label.
2. Referenced Documents
2
2.1 ASTM Standards:
5. Labeling Recommendations
F2727 Guide for Manufacturers for Labeling Headgear
5.1 Each exoskeleton should have a product label perma-
Products
nently and visibly attached, stamped, or printed.
F1301 Practice for Labeling Chemical Protective Clothing
3
5.2 Multiple label pieces should be permitted in order to
2.2 U.S. Code of Federal Regulations:
21 CFR 890.3480 Powered lower extremity exoskeleton carry all statements and information on the product label.
4
Instructional manuals and promotional material are not consid-
2.3 Other Standards:
ered part of the label.
ISO 7000 / IEC 60417 Graphical symbols for use on
equipment
5.3 All label text should be written at least in a language
which the intended users can understand.
5.4 Symbols and other graphical information, such as ISO
1
This practice is under the jurisdiction of ASTM Committee F48 on Exoskel-
7000 / IEC 60417 graphical symbols, should be permitted to be
etons and Exosuits and is the direct responsibility of Subcommittee F48.01 on
Design and Manufacturing.
used to supplement text on the product label(s) and should be
Current edition approved Dec. 1, 2018. Published December 2018. DOI:
explained in the user documentation materials.
10.1520/F3358-18.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
5.5 The label should include at least the following informa-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
1
tion. All letters should be at least 2 mm ( ⁄16 in.) high:
Standards volume information, refer to the standard’s Document Summary page on
5.5.1 Manufacturer’s name, identification, or designation.
the ASTM website.
3
5.5.2 Model, style, or serial number, or combinations
Available from U.S. Government Printing Office, Superintendent of
Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
thereof.
www.access.gpo.gov.
5.5.3 Lot number or designation – may be incorporated in
4
Available from International Organization for Standardization (ISO), ISO
the serial number.
Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
Geneva, Switzerland, http://www.iso.org. 5.5.4 Date of manufacture – uncoded month and year.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3358 − 18
5.5.5 Warnings, cautions, limitations, precautions, notes, 6.3.3 Instructions on fitting the user and adjustment
contraindications, and information related to the
...

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5.1 The significance of the information to be recorded in a test report allows for exoskeleton safety and performance to be contextualized with the exoskeleton configuration. Exoskeleton tests can also be replicated across similar or different exoskeletons by using this practice to record the exoskeleton test configuration in a standardized way.  
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1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 Obstacles can vary greatly in, for example: length, width, height, quantity, geometry, and for a variety of industries. Fig. 2 shows examples of various obstacles.  
FIG. 2 Example Obstacles in: (a) Road Construction; (b) Warehouse; (c) Manufacturing: Floor; (d) Manufacturing: Overhead; (e) Military Obstacle Course  
5.2 Exoskeletons are being used in the industrial/occupational, military, response, medical, and recreational sectors to enhance safety and effectiveness of the user to perform tasks. Many tasks involve avoiding obstacles, and may include for example, upper, lower, or full body movement in order to complete the task. As there are infinite obstacles and ways that obstacle courses can be designed, this test method addresses obstacle avoidance while walking through a standard set of obstacles. Dependent upon the task, it may require people to traverse various environmental conditions (for example, ground) and avoid obstacles while wearing an exoskeleton. For example, an exoskeleton may be used to help during construction or in medical facilities where workers in exoskeletons avoid obstacles with and without carrying loads as part of their daily activities. In military, manufacturing, and response areas, exoskeleton users may for example, step over or under, side-step between, or walk around obstacles, or combinations thereof, to perform the task at hand. Variations to obstacle avoidance may include, for example, increased user speed/momentum, load handling, and distractions that may change user performance when avoiding obstacles. The testing results of exoskeletons shall describe, in a statistically significant way (see guidance in Appendix X1), how reliably the exoskeleton is able to support tasks within the specified types of environments, confinements, and terrains, and thus provide sufficiently high levels of confidence to determine the applicability of the exoskeleton.  
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1.1 Purpose:  
1.1.1 The purpose of this test method, as a part of a suite of exoskeleton use test methods, is to quantitatively evaluate an exoskeleton’s (see Terminology F3323) safety (see 1.4) or performance, or both, when avoiding obstacles.  
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Standard Test Method for Exoskeleton Use: Beams

SIGNIFICANCE AND USE
5.1 Beams and beams with platforms can vary greatly in, for example: length, width, height, quantity, geometry, surface coatings, and for a variety of industries. Fig. 2 shows examples of various beams and beams with platforms.
FIG. 2 Example Beams: (a) Steel Construction Beams; (b) Steel Construction Beam to a Platform; (c) Log Construction Beam; (d) Playground Log Beam; (e) Log Beam across Water; and (f) Balance Beam used for Gymnastics  
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SIGNIFICANCE AND USE
5.1 The significance of the information to be recorded in a test report allows for exoskeleton safety and performance to be contextualized with the exoskeleton user. Exoskeleton test results can be compared across users to determine exoskeleton usefulness, exoskeleton capability for particular users or groups of users, and standardized reporting of user information allows organizations to better replicate tests.  
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5.3.5 Tables D7878/D7878M,  
5.3.6 Tables D6960/D6960M,  
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5.3.8 Tables D8241/D8241M,  
5.3.9 Practice E3003,  
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SCOPE
1.1 This practice describes a means to record the exoskeleton user information when testing. The practice provides a method for recording exoskeleton user: general information, measurements, activity level, experience with exoskeletons, prior injuries, and other pertinent information that may impact exoskeleton testing.  
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SIGNIFICANCE AND USE
5.1 The significance of the information to be recorded in a test report allows for exoskeleton safety and performance to be contextualized with the exoskeleton fit to the user. Exoskeleton tests can also be replicated across similar or different exoskeletons by using this practice to record the exoskeleton fit to the user for a test in a standardized way.  
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5.4 Additional fit and measurement information may be found in Terminology D5219, Practice E3003, and Practice F1731.
SCOPE
1.1 This practice describes a means to record the exoskeleton fit to the user when testing. The practice provides a method for recording exoskeleton: alignment to the user, component distances from the body, sizing, and subjective comfort using a standard recording method.  
1.2 This practice is intended to be used with other exoskeleton test methods and practices to provide a clear representation of the exoskeleton fit to the user measured along body planes; provides a basis for comparison of the test circumstances across different exoskeletons or tests, or both; and allows a test to be recreated.  
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SIGNIFICANCE AND USE
5.1 Exoskeletons are being used in the industrial/occupational, military, response, medical, and recreational sectors to enhance safety and effectiveness of the user to perform tasks. Traversing gaps is a component of many tasks that someone would do with an exoskeleton. For example, an exoskeleton may be used to help a worker in building construction where gaps in ground surfaces are prevalent. In the military, and other similar environments, soldiers using exoskeletons may traverse gaps along paths carrying loads. Fig. 1 shows examples of gaps typically found in various environments in which persons using exoskeletons may be required to step over gaps. The testing results of exoskeletons shall describe, in a statistically significant way, how reliably the exoskeleton is able to support tasks within the specified types of environments, confinements, and terrains, and thus provide sufficiently high levels of confidence to determine the applicability of the exoskeleton to a given task.  
5.2 This test method addresses exoskeleton safety and performance requirements expressed by manufacturing, medical, emergency responders, military, or other organizations requesting this test. The safety and performance data captured within this test method are indicative of the test exoskeleton’s and the exoskeleton user’s capabilities. The safety and performance data from these tests are essential to guiding the procurement and deployment decisions of exoskeleton purchasers and users.  
5.3 The standard test setup and apparatus (see Section 6) is specified to be easily fabricated. This facilitates evaluation and replication of gap tests by exoskeleton sectors. The standard test setup and apparatus can also be used to support training (see Practice F3444/F3444M) and to establish proficiency of exoskeleton users, as well as provide manufacturers with information about the usefulness of their exoskeleton(s) for tasks.  
5.4 Although the test method was developed for the sectors lis...
SCOPE
1.1 Purpose:  
1.1.1 The purpose of this test method, as a part of a suite of exoskeleton use test methods, is to quantitatively evaluate an exoskeleton’s (see Terminology F3323) performance or safety, or both, of usage by the exoskeleton user (see 1.4) for gaps.  
1.1.2 Exoskeletons shall possess a certain set of allowable exoskeleton user movement capabilities, including user-motion adaptability, to suit operations such as: industrial/occupational, military, response, medical, or recreational. Environments in these typical sectors often pose constraints to exoskeleton user movement to various degrees. Being able to step over gaps, as intended by the user or test requestor, while using an exoskeleton is essential for exoskeleton deployment for a variety of tasks. This test method specifies test setup, procedure, and recording to standardize this gaps task for testing exoskeleton user movement.  
1.1.3 Exoskeletons need to function as intended, regardless of types of tasks and terrain complexities (for example, carpet, metal, masonry, rock, wood). Required movement capabilities may include, for example: walking, running, crawling, climbing; traversing gaps, stairs, slopes, various types of floor surfaces or terrains, or confined spaces, or combinations thereof. Standard test methods are required to evaluate whether or not exoskeletons meet these requirements.  
1.1.4 ASTM Subcommittee F48.03 develops and maintains international standards for task performance and environmental considerations that include but are not limited to, standards for safety, quality, and efficiency. This subcommittee aims to develop standards for any exoskeleton application as exemplified as in 1.1.2. The F48.03 test suite consists of a set of test methods for evaluating exoskeleton capability requirements. This gaps test method is a part of the test suite. The setup, procedure, and apparatuses associated with the test methods challenge speci...

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SIGNIFICANCE AND USE
5.1 Hurdle designs can vary greatly in, for example: hurdle geometry, surface coatings, and coverings for a variety of industries. Fig. 1 shows examples of various hurdles.  
5.2 Exoskeletons are being used in the industrial/occupational, military, response, medical, and recreational sectors to enhance safety and effectiveness of the user to perform tasks. Hurdles are used in many tasks performed and may include, for example, upper, lower, or full body movement in order to complete the task. For example, an exoskeleton may be used to help rehabilitate a patient who suffered a traumatic injury. And in manufacturing, warehousing, and other occupations, and other similar environments, workers in exoskeletons may traverse hurdles (for example, obstacles) in the walkways while carrying or not carrying loads, indoors or outdoors, as part of their daily activities. The testing results of exoskeletons shall describe, in a statistically significant way, how reliably the exoskeleton is able to support tasks within the specified types of environments, confinements, and terrains, and thus provide sufficiently high levels of confidence to determine the applicability of the exoskeleton.  
5.3 This test method addresses exoskeleton safety and performance requirements expressed by manufacturing, emergency responders, military, or other organizations requesting this test. The safety and performance data captured within this test method are indicative of the test exoskeleton’s and the exoskeleton user’s capabilities. Having available direct information from tested exoskeleton(s) with associated performance data to guide procurement and deployment decisions is essential to exoskeleton purchasers and users.  
5.4 The testing results of the candidate exoskeleton(s) shall describe, in a statistically significant way, how reliably the exoskeleton user is able to negotiate hurdles. The test apparatus described in Section 6 is intended to be a single or set of hurdles where repeatable re...
SCOPE
1.1 Purpose:  
1.1.1 The purpose of this test method, as a part of a suite of exoskeleton use test methods, is to quantitatively evaluate an exoskeleton’s (see Terminology F3323) safety (see 1.4) or performance, or both, for traversing hurdles.  
1.1.2 Exoskeletons possess a certain set of allowable exoskeleton user movement capabilities, including user-motion adaptability, to suit operations such as: industrial/occupational, military, response, medical, or recreational. Environments in these typical sectors often pose constraints to exoskeleton user movement to various degrees. Being able to traverse hurdles, as intended by the user or test requestor, while using an exoskeleton is essential for exoskeleton deployment for a variety of tasks (for example, traversing logs, objects). This test method specifies test setup, procedure, and recording to standardize this hurdles task for testing exoskeleton user movement.  
1.1.3 Exoskeletons need to function as intended, regardless of types of tasks and terrain complexities (for example, carpet, metal, masonry, rock, wood). Required movement capabilities may include, for example: walking, running, crawling, climbing, traversing gaps, hurdles, stairs, slopes, various types of floor surfaces or terrains, or confined spaces, or any combination thereof. Standard test methods are required to evaluate whether or not exoskeletons meet these requirements.  
1.1.4 ASTM Subcommittee F48.03 develops and maintains international standards for task performance and environmental considerations that include but are not limited to, standards for safety, quality, and efficiency. This subcommittee aims to develop standards for any exoskeleton application as exemplified as in 1.1.2. The F48.03 test suite consists of a set of test methods for evaluating exoskeleton capability requirements. This hurdles test method is a part of the test suite. The setup, procedure, and apparatuses associated wi...

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Standard Test Method for Evaluating Exoskeleton Fall Risk due to Stumbling

SIGNIFICANCE AND USE
5.1 There is strong evidence that exoskeletons can physically augment and assist users. They are typically designed and optimized with specific tasks in mind and initially tested in controlled lab or field settings. However, in the real world exoskeletons encounter less structured environments and situations (for example, hospital rooms, factory floors, construction sites, or even personal homes). In order to accelerate the adoption of exoskeletons in society, understanding their safety in the presence of perturbations is helpful. The testing results of the exoskeleton shall describe the extent to which the exoskeleton improves, inhibits, or maintains a user’s ability to recover from stumbles, thus providing exoskeleton wearers and prescribers (for example, patients, clinicians, industry leaders, factory workers) with additional information about device performance and expectations.  
5.2 The standard test apparatus and setup (see Section 6) is specified to be easily fabricated and implemented in gait or motion analysis laboratories. Variants of the apparatus, control algorithm, and test setup are acceptable to allow implementation in various lab settings with ranging experimental capabilities. The standard test setup and apparatus can also be used to support training and establish proficiency of exoskeleton users, as well as provide manufacturers with information about the performance of their exoskeleton(s) for tasks.
SCOPE
1.1 Purpose:  
1.1.1 The purpose of this test method is to evaluate the extent to which an exoskeleton (see Section 3) improves, inhibits, or maintains (that is, does not affect) a user’s ability to recover from a stumble perturbation.  
1.1.2 Exoskeletons are designed to assist specific tasks and initially tested in controlled lab or controlled field settings. However, in the real world exoskeletons encounter less structured environments and situations (for example, hospital rooms, factory floors, construction sites). Even without exoskeletons people will stumble (that is, trip) or scuff their foot. It would be helpful to understand how wearing an exoskeleton affects a person’s ability to recover from a stumble perturbation. Is one’s ability to recover hampered, enhanced, or unaltered when using an exoskeleton? This test method specifies test setup, procedure, and recording to standardize testing exoskeleton user stumble recovery.  
1.2 Performing Location—This test method shall be performed in a testing laboratory where the specified apparatus and environmental conditions are available and implemented.  
1.3 Units—The values stated in SI units are to be regarded as the standard. The values given in parentheses are not precise mathematical conversions to inch-pound units. They are close approximate equivalents for the purpose of specifying material dimensions or quantities that are readily available to avoid excessive fabrication costs of test apparatuses while maintaining repeatability and reproducibility of the test method results. These values given in parentheses are provided for information only and are not considered standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM F3519-21(Guide)
Standard Guide for Establishing a Reporting Structure for Exoskeleton Analysis

SIGNIFICANCE AND USE
3.1 This guide describes a template of written considerations that should be provided by the manufacturer to the purchaser related to the documenting of exoskeleton analysis. Adherence to this guide allows analysis results of varied exoskeleton manufacturers to be compared by a purchaser with respect to their end user needs.  
3.2 Not every element of this guide may be applicable to all exoskeleton components or configurations. It is the manufacturer’s responsibility to determine which portions of this guide are applicable to their exoskeletons for analysis reporting.
SCOPE
1.1 This guide provides a structure for exoskeleton manufacturers to document their analysis. Furthermore, this guide should be used in conjunction with Practice F3474, Guide F3518, Standard Guide for The Application of Ergonomics to Prevent Injury During Exoskeleton Use2 and other future documents.  
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM F3474-20(Practice)
Standard Practice for Establishing Exoskeleton Functional Ergonomic Parameters and Test Metrics

SIGNIFICANCE AND USE
2.1 This practice describes what measure should be performed during the near (hours/days), mid (days/weeks), and far (months/years) stages of exoskeleton evaluation (Fig. 1). The functional conditions and metrics with respect to each task method are assessed from the body area(s) impacted by the exoskeleton (for example, upper body, lower body, or both). These may be within as well as distant to the body areas impacted by the exoskeleton (for example, an upper body exoskeleton may have impacts on the trunk and spine). Desired effects as well as unintended encumbrances to the user’s body are important considerations. The evaluation will occur within the context relevant to the end-use application of the exoskeleton’s implementation. This practice pertains to the industry, military, medical, first responders, and recreational domains, but other domains may arise in the future and will need to be considered. Each domain is unique unto itself; however, the task methods and metrics collected may be unique or overlap across any number of user domains.
FIG. 1 Exoskeleton Assessment Decision Tree  
2.2 Task methods and their metrics are either administered in a laboratory environment, field environment, or both laboratory and field environments. Where not otherwise specified, patient functional outcome measures and pain are key metrics that should be considered for testing performed in the medical domain. Exoskeleton producers or researchers, or both, may also want to consider different types of imaging such as X-rays, computed tomography (CT) scans, magnetic resonance imaging (MRI), ultrasound, and nuclear medicine imaging. Additionally, exoskeleton producers or researchers, or both, may also wish to carry out neuroimaging such as, but not limited to, structural and functional and diffusion MRI, magnetoencephalography (MEG), electroencephalography (EEG), positron emission tomography (PET), or near infrared spectroscopy (NIRS) to understand the cognitive and neurophysiol...
SCOPE
1.1 This practice provides a recommended approach and a set of options for assessing one or more specific ergonomic parameters with respect to human users of exoskeletons.  
1.2 This practice provides functional ergonomic criteria to consider for the design, production, and evaluation of exoskeletons within the domains of industry, military, medical, first responders, and recreational. When designing exoskeletons, natural unassisted human kinematics and kinetics, as well as the resulting strain and fatigue experienced by the user should be salient design parameters. Any changes in the natural unassisted human kinematics and kinetics may impact the exoskeleton’s effectiveness in augmenting user performance. Therefore, the defining principle of this practice is to establish objective measures that can be selected from to assess human kinematics and kinetics, as well as the resulting strain and fatigue experienced by the user within the task context of the exoskeleton’s end use application.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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